The recommended dose of Bextra (valdecoxib) for the relief of the signs and symptoms of arthritis is 10 mg once daily. The recommended dose of Bextra for treatment of primary dysmenorrhea is 20 mg twice daily, as needed. Bextra (valdecoxib) may interact with aspirin, ACE-inhibitors, furosemide, thiazide diuretics, anticonvulsants, lithium, anticoagulants, ketoconazole and fluconazole, oral contraceptives, and diazepam. Tell your doctor all medications and supplements you use. In late pregnancy Bextra should be avoided because it may cause premature closure of the ductus arteriosus. It is not known whether Bextra is otherwise harmful to a developing fetus. It is also not known whether Bextra is present in human breast milk.

Our Bextra (valdecoxib) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SIDE EFFECTS

Of the patients treated with BEXTRA Tablets in controlled arthritis trials, 2665 were patients with OA,
and 2684 were patients with RA. More than 4000 patients have received a chronic total daily dose of
BEXTRA 10 mg or more. More than 2800 patients have received BEXTRA 10 mg/day, or more, for at
least 6 months and 988 of these have received BEXTRA for at least 1 year.

Osteoarthritis And Rheumatoid Arthritis

Table 4 lists all adverse events, regardless of causality, that occurred in ≥2.0% of patients receiving
BEXTRA 10 and 20 mg/day in studies of three months or longer from 7 controlled studies conducted in
patients with OA or RA that included a placebo and/or a positive control group.

Postmarketing Experience

The following reactions have been identified during postmarketing use of BEXTRA. These reactions
have been chosen for inclusion either due to their seriousness, reporting frequency, possible causal
relationship to BEXTRA, or a combination of these factors. Because these reactions were reported
voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or
establish a causal relationship to drug exposure.